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DATAMONITOR: Battlefor HIV drug market share getting fiercer - maybe
too fierce for some
(M2 PressWIRE Via Acquire Media NewsEdge)
RDATE:24092008
London -- The HIV market, worth $9.3 billion in 2007, is expected to
grow to $15.1 billion by 2017, driven by the increasing prevalence of
HIV worldwide and the longer life expectancy of patients receiving
treatment. Despite this growth, the competition is getting tougher
across all antiretroviral drug classes. New efficacy and side-effect
data on GlaxoSmithKline's (GSK) nucleoside reverse transcriptase
inhibitor (NRTI) fixed-dose combination Epzicom and results from two
major trials on the use of Protease Inhibitors, will significantly
change the dynamics within their respective classes. The first
integrase inhibitor, Merck & Co's Isentress, launched in the autumn of
2007, is further intensifying the competition. According to a new
report by independent market analyst Datamonitor, competition is
becoming so intense some big players in the HIV market may eventually
be either squeezed, or opt out.
$15 billion market by 2017 In 2007, HIV drugs generated sales of $9.3
billion across the seven major markets (7MM**), expanding with a
compound annual growth rate (CAGR) of 11.3% (2004-2007). Over the next
10 years Datamonitor expects the market's growth to slow down somewhat,
but still reach total sales of $15.1 billion in 2017. Despite the
increasing prevalence of HIV, factors such as the rising emphasis on
cost containment, combined with patent expiries of key marketed drugs
could inhibit future expansion. At the same time, newly launched drugs
and drug classes and the greater number of patients accessing treatment
will counteract these effects and contribute to the growth of the
market. Patient numbers will rise predominantly because of an increased
life expectancy, a steady number of new infections and immigration from
areas of high prevalence to the 7MM.
Although the 7MM are commercially the most significant for HIV, they in
factonly account for three to six percent of the globally infected
population. HIV prevalence across the rest of the world is much higher,
and access to antiretroviral therapy has been improving in low and
middle-income countries. Thus, many pharmaceutical companies are
turning towards fast-growing emerging markets as new sources of revenue
growth.Among the former 7MM countries, Canada's HIV market was worth
$272 million in 2007, growing at a CAGR of 24% from 2004-2007. While
larger than Japan's, it remains smaller than any of the big five EU***
markets. Given Canada's high HIV prevalence compared with Japan and
reasonable price levels, Datamonitor believes there are significant
opportunities within this market.
The battle for market share is getting fiercer The HIV market is
dominated by just a few companies. Gilead is the current market leader
with a portfolio of four marketed products and an integrase inhibitor
in late stage development, says Datamonitor infectious diseases analyst
Mansi Shah. "The Californian biotech company's NRTI fixed dose
combination (FDC) Truvada remained the bestselling drug in 2007 with
revenues of $1.5 billion, while Atripla, a novel cross-class fixed-dose
combination brand only available in the US in 2007 generated sales of
$920 million.
"Atripla, a joint venture between Gilead and Bristol-Myers Squibb
(BMS), rapidly established itself as the new gold standard for newly
diagnosed patients. By 2007 it was the fourth best selling HIV drug
worldwide despite only being available in the US," she says.
A changing of the guard? GSK, the market leader for much of the
history of antiretroviral therapy, has eight marketed products, but
many of its brands are relatively old and face patent expiration. In
addition, several late-stage R&D setbacks over the past two years have
left the company bereft of any HIV compounds in clinical development.
The company had to face further problems this year when several
independent studies highlighted that GSK's main hope Epzicom, an FDC
competing with Gilead's Truvada, is both less efficacious in certain
patients and associated with an increased risk of myocardial
infarction, Ms. Shah says. "These data from the ACTG5202 and SMART
trials and the D:A:D cohort come on top of the well known risk of
hypersensitivity reactions to Epzicom's abacavir component." The
competition within the Protease Inhibitor (PI) class has also
intensified. Two trials, the CASTLE and ARTEMIS studies, are largely
responsible for changing the dynamics here. Kaletra, the previously
undisputed leader has come out looking slightly, if not always
statistically significantly, worse than the two newer challengers,
BMS's Reyataz and Tibotec /Johnson & Johnson's Prezista. Although
Kaletra continued to lead in the EU and Japan in terms of sales in
2007, Reyataz has been the number one in the US market for the last
three years. Datamonitor expects the EU to favor Reyataz as well once
it receives first line approval there, probably in 2009.
With no HIV candidates in the pipeline Abbott's commitment to the
sector beyond Kaletra and Norvir remains doubtful. By 2017, Datamonitor
anticipates Reyataz and Prezista to become the leading PIs across the
7MM, pushing Kaletra out from leading to third PI. Despite Reyataz's
success, BMS' overall franchise success is also at risk with Sustiva's
patent expiry in 2013, because the company has no visible follow-up
compounds in development to make up for the shortfall. Tibotec on the
other hand is in a better position thanks to two successfully approved
products and one late stage candidate, likely strengthening its
presence in HIV over the next 10 years.
In the space of just five months between September 2007 and January
2008, three new HIV drugs were approved by the regulators for the first
time: Pfizer's Selzentry, Merck & Co's Isentress and Tibotec's
Intelence. Isentress and Intelence are already being widely used in
highly active antiretroviral therapy(HAART) regimens for treatment
experienced patients, but Selzentry's launch has been very sluggish.
Datamonitor has found that Intelence, a novel non-nucleoside reverse
transcriptase inhibitor(NNRTI), is being used as early as second line
therapy despite the lack of supporting data for this patient group.
This off-label use risks cannibalizing the future franchise of
Tibotec's second NNRTI TMC278, which is targeted specifically at the
treatment-nave population this market, when launched around 2011.
Building on Isentress' efficacy and benign side-effect profile, Merck &
Co. is pursuing approval for Isentress in the much larger early-stage
and treatment-nave patient population. Since traditionally a dual NRTI
backbone in combination with either an NNRTI or a PI form the first
line treatment, it is still unclear how integrase inhibitors drugs will
fit in, Ms. Shah says. "Many different combinations are currently being
investigated in various clinical trials. Given the optimism surrounding
Isentress, integrase inhibitors have the potential to change first line
regimens significantly over the next 10 years and really make a mark in
this increasingly difficult market," she says.
Notes for editors
* Commercial Insight: HIV - The battle for market share is getting
fiercer
** The seven major markets (7MM) are France, Germany, Italy, Japan,
Spain, UK and US.
*** The big five' EU markets are France, Germany, Italy, Spain and the
UK.
Datamonitor's report Commercial Insight: HIV - The battle for market
share is getting fiercer provides assessment and forecast for marketed
and late-stage development antiretrovirals in the 7MM, including a
snapshot of ROW snapshot and a case study on the Canadian market, which
surpasses Japan's in size for this indication.
Ms. Mansi Shah, Datamonitor infectious diseases analyst and report
author is available for comment.
CONTACT: Matthew Dick, Datamonitor
Tel: +44 (0)20 7765 7824
e-mail: mdick@datamonitor.com
Suzanna Eygabroat, Datamonitor, New York
Tel: +1 585 374 6236 ext 17
e-mail: seygabroat@datamonitor.com
Denis Mason, Datamonitor, Sydney
Tel: +61 2 8705 6903
e-mail: dmason@datamonitor.com
WWW: http://www.datamonitor.com
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Copyright ? 2008 M2 Communications Ltd.
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